Sarepta Therapeutics announced that the U.S. FDA has accepted the Company’s Biologics License Application for SRP-9001 gene therapy for treatment of ambulant individuals with Duchenne muscular dystrophy.
SRP-9001 has been granted Priority Review by the U.S FDA with regulatory action date of May 29,2023.
SRP-9001, an investigational gene therapy for Duchenne muscular dystrophy is being developed in partnership with Roche to treat the underlying cause of Duchenne by delivering a functional, shortened dystrophin to the muscle.
Please find Sarepta’s press release here:
Please find information here on Roche UK’s position following Sarepta’s FDA Biologics Licence Application submission:
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